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Anti-Oxidant Effect on Peritoneal Membrane in Peritoneal Dialysis (PD) Patients

Primary Purpose

End-Stage Kidney Disease, Peritoneal Dialysis

Status

Unknown status

Phase

Phase 4

Locations

Korea, Republic of

Study Type

Interventional

Intervention

N-acetylcysteine

About this trial

This is an interventional treatment trial for End-Stage Kidney Disease focused on measuring Antioxidant, Epithelial to Mesenchymal Transition, peritoneal fibrosis, Peritoneal Dialysis, Continuous Ambulatory

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Maintenance peritoneal dialysis at least 3 months
Patients who are able and willing to understand, sign and date an informed consent document, and authorize access to protected health information

Exclusion Criteria:

Episode of peritonitis at least 3 months
Episodes of admission due to other disease at lease 3 months
Liver disease
Allergic history with N-acetylcysteine

Sites / Locations

Ewha Womans University Mokdong HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

N-acetylcysteine

Arm Description

Age and sex matched peritoneal dialysis patients

N-acetylcysteine in stable peritoneal dialysis patients

Outcomes

Primary Outcome Measures

Peritoneal membrane function

Changes in peritoneal membrane function (Δ D/Pcreatinine, ΔD/Purea) with peritoneal equilibrium test

Secondary Outcome Measures

Oxydative stress status

Measurement of oxydative stress status with plasma and RBC (GSH/GSSG, 8-OHdG)

Mesothelial cell transformation (Epithelial to Mesenchymal Transition)

Morphology was analysed with peritoneal dialysate isolated mesothelial cell

Residual renal function

Changes in residual renal function (ΔKt/Vurea, ΔeGFR)

Peritoneal membrane function

Changes in peritoneal membrane function (Δ D/Pcreatinine, ΔD/Purea) with peritoneal equilibrium test

Full Information

NCT ID

NCT01111422

First Posted

April 23, 2010

Last Updated

April 26, 2010

Sponsor

Ewha Womans University

1. Study Identification

Unique Protocol Identification Number

NCT01111422

Brief Title

Anti-Oxidant Effect on Peritoneal Membrane in Peritoneal Dialysis (PD) Patients

Official Title

A Randomized Prospective Trial of N-acetyl Cystein in Patients With Peritoneal Dialysis

Study Type

Interventional

2. Study Status

Record Verification Date

March 2010

Overall Recruitment Status

Unknown status

Study Start Date

March 2010 (undefined)

Primary Completion Date

December 2010 (Anticipated)

Study Completion Date

December 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Ewha Womans University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Peritoneal fibrosis is one of the major causes of technical failure in patients on peritoneal dialysis (PD) for long period of time. Although the exact mechanisms of peritoneal damage during PD still remain unclear, generation of reactive oxygen species may be responsible for progressive membrane dysfunction. N-acetylcysteine (NAC)is a powerful antioxidant shown to protect peritoneal fibrosis in peritoneal dialysis animal model. In this study the researchers investigated the hypothesis that NAC protect peritoneal membrane damage.

Detailed Description

N-Acetylcysteine (NAC) is known to be relatively safe and beneficial in peritoneal dialysis patient at a dose of 1200 mg per day. Patients will be randomly assigned to NAC and control group and prescribed according to the protocol. At 2 and 6 month, Peritoneal equilibrium test (PET) will be performed with blood sampling.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

End-Stage Kidney Disease, Peritoneal Dialysis

Keywords

Antioxidant, Epithelial to Mesenchymal Transition, peritoneal fibrosis, Peritoneal Dialysis, Continuous Ambulatory

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Control

Arm Type

No Intervention

Arm Description

Age and sex matched peritoneal dialysis patients

Arm Title

N-acetylcysteine

Arm Type

Experimental

Arm Description

N-acetylcysteine in stable peritoneal dialysis patients

Intervention Type

Drug

Intervention Name(s)

N-acetylcysteine

Other Intervention Name(s)

Muteran capsuleⓇ HAN WHA PHARM.

Intervention Description

N-acetylcysteine (200 mg/capsule) 1200 mg/day (600 mg bid) for 6 months

Primary Outcome Measure Information:

Title

Peritoneal membrane function

Description

Changes in peritoneal membrane function (Δ D/Pcreatinine, ΔD/Purea) with peritoneal equilibrium test

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Oxydative stress status

Description

Measurement of oxydative stress status with plasma and RBC (GSH/GSSG, 8-OHdG)

Time Frame

6 months

Title

Mesothelial cell transformation (Epithelial to Mesenchymal Transition)

Description

Morphology was analysed with peritoneal dialysate isolated mesothelial cell

Time Frame

6 month

Title

Residual renal function

Description

Changes in residual renal function (ΔKt/Vurea, ΔeGFR)

Time Frame

6 month

Title

Peritoneal membrane function

Description

Changes in peritoneal membrane function (Δ D/Pcreatinine, ΔD/Purea) with peritoneal equilibrium test

Time Frame

2 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Maintenance peritoneal dialysis at least 3 months Patients who are able and willing to understand, sign and date an informed consent document, and authorize access to protected health information Exclusion Criteria: Episode of peritonitis at least 3 months Episodes of admission due to other disease at lease 3 months Liver disease Allergic history with N-acetylcysteine

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mina Yu, MD

Phone

+82-2-2650-2562

yuelizabeth@hanmail.net

First Name & Middle Initial & Last Name or Official Title & Degree

Hyun-Jung Kim, NR

Phone

+82-2-2650-5497

40739@eumc.co.kr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Duk-Hee Kang, MD. PhD.

Organizational Affiliation

Ewha Womans University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Ewha Womans University Mokdong Hospital

City

Seoul

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mina Yu, MD

Phone

+82-2-2650-2562

yuelizabeth@hanmail.net

First Name & Middle Initial & Last Name & Degree

Hyun Jung Kim, Nurse

Phone

+82-2-2650-5497

First Name & Middle Initial & Last Name & Degree

Duk-Hee Kang, Professor

12. IPD Sharing Statement

Learn more about this trial

Anti-Oxidant Effect on Peritoneal Membrane in Peritoneal Dialysis (PD) Patients

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